'The baby will have the right beginning': a qualitative study on mother and health worker views on point-of-care HIV birth testing across 10 sites in Zimbabwe.

BACKGROUND: The survival of HIV-infected infants depends on early identification and initiation on effective treatment. HIV-exposed infants are tested at 6 weeks of age; however, testing for HIV sooner (e.g., shortly after birth) can identify in utero infection, which is associated with rapid progression. Infant early diagnostic virologic tests often have long turnaround times, reducing the utility of early testing. Point-of-care (POC) testing allows neonates born in health facilities to get results prior to discharge. This study aimed to understand the views of mothers and health workers regarding the use and acceptability of POC birth testing. METHODS: Beginning in 2018, Zimbabwe offered standard HIV testing at birth to high-risk HIV-exposed infants; as part of a pilot program, at 10 selected hospitals, POC birth testing (BT) was offered to every HIV-exposed infant. In order to understand experiences at the selected sites, 48 interviews were held: 23 with mothers and 25 with health workers, including 6 nurses-in-charge. Participants were purposively sampled across the participating sites. Interviews were held in English, Shona, or Ndebele, and transcribed in English. Line-by-line coding was carried out, and the constant comparison method of analysis was used to identify key themes for each respondent type. RESULTS: Findings were organized under four themes: challenges with BT, acceptability of BT, benefits of BT, and recommendations for BT programs. Overall, BT was well accepted by mothers and health workers because it encouraged mothers to better care for their uninfected newborns or initiate treatment more rapidly for infected infants. While the benefits were well understood, mothers felt there were some challenges, namely that they should be informed in advance about testing procedures and tested in a more private setting. Mothers and HCWs also recommended improving awareness of BT, both among health care workers and in the community in general, as well as ensuring that facilities are well-stocked with supplies and can deliver results in a timely way before scaling up programs. CONCLUSIONS: Mothers and health workers strongly support implementation and expansion of birth testing programs due to the benefits for newborns. The challenges noted should be taken as planning guidance, rather than reasons to delay or discontinue birth testing programs.

"It went through the roof": an observation study exploring the rise in PrEP uptake among Zimbabwean female sex workers in response to adaptations during Covid-19.

INTRODUCTION: Sisters with a Voice (Sisters), a programme providing community-led differentiated HIV prevention and treatment services, including condoms, HIV testing, pre-exposure prophylaxis (PrEP) and antiretroviral therapy linkage for sex workers, reached over 26,000 female sex workers (FSW) across Zimbabwe in 2020. Zimbabwe's initial Covid "lockdown" in March 2020 and associated movement restrictions interrupted clinical service provision for 6 weeks, particularly in mobile clinics, triggering the adaptation of services for the Covid-19 context and a scale up of differentiated service delivery (DSD) models. PrEP service delivery decentralized with shifts from clinical settings towards community/home-based, peer-led PrEP services to expand and maintain access. We hypothesize that peer-led community-based provision of PrEP services influenced both demand and supply-side determinants of PrEP uptake. We observed the effect of these adaptations on PrEP uptake among FSW accessing services in Sisters in 2020. METHODS: New FSW PrEP initiations throughout 2020 were tracked by analysing routine Sisters programme data and comparing it with national PrEP initiation data for 2020. We mapped PrEP uptake among all negative FSW attending services in Sisters alongside Covid-19 adaptations and shifts in the operating environment throughout 2020: prior to lockdown (January-March 2020), during severe restrictions (April-June 2020), subsequent easing (July-September 2020) and during drug stockouts that followed (October-December 2020). RESULTS AND DISCUSSION: PrEP uptake in 2020 occurred at rates <25% (315 initiations or fewer) per month prior to the emergence of Covid-19. In response to Covid-19 restrictions, DSD models were scaled up in April 2020, including peer demand creation, community-based delivery, multi-month dispensing and the use of virtual platforms for appointment scheduling and post-PrEP initiation support. Beginning May 2020, PrEP uptake increased monthly, peaking at an initiation rate of 51% (n = 1360) in September 2020. Unexpected rise in demand coincided with national commodity shortages between October and December 2020, resulting in restriction of new initiations with sites prioritizing refills. CONCLUSIONS: Despite the impact of Covid-19 on the Sisters Programme and FSW mobility, DSD adaptations led to a large increase in PrEP initiations compared to pre-Covid levels demonstrating that a peer-led, community-based PrEP service delivery model is effective and can be adopted for long-term use.

Impact of Routine Point-of-Care Versus Laboratory Testing for Early Infant Diagnosis of HIV: Results From a Multicountry Stepped-Wedge Cluster-Randomized Controlled Trial.

BACKGROUND: Although the World Health Organization recommends HIV-exposed infants receive a 6-week diagnostic test, few receive results by 12 weeks. Point-of-care (POC) early infant diagnosis (EID) may improve timely diagnosis and treatment. This study assesses the impact of routine POC versus laboratory-based EID on return of results by 12 weeks of age. METHODS: This was a cluster-randomized stepped-wedge trial in Kenya and Zimbabwe. In each country, 18 health facilities were randomly selected for inclusion and randomized to timing of POC implementation. FINDINGS: Nine thousand five hundred thirty-nine infants received tests: 5115 laboratory-based and 4424 POC. In Kenya and Zimbabwe, respectively, caregivers were 1.29 times [95% confidence interval (CI): 1.27 to 1.30, P < 0.001] and 4.56 times (95% CI: 4.50 to 4.60, P < 0.001) more likely to receive EID results by 12 weeks of age with POC versus laboratory-based EID. POC significantly reduced the time between sample collection and return of results to caregiver by an average of 23.03 days (95% CI: 4.85 to 21.21, P < 0.001) in Kenya and 62.37 days (95% CI: 58.94 to 65.80, P < 0.001) in Zimbabwe. For HIV-infected infants, POC significantly increased the percentage initiated on treatment, from 43.2% to 79.6% in Zimbabwe, and resulted in a nonsignificant increase in Kenya from 91.7% to 100%. The introduction of POC EID also significantly reduced the time to antiretroviral therapy initiation by an average of 17.01 days (95% CI: 9.38 to 24.64, P < 0.001) in Kenya and 56.00 days (95% CI: 25.13 to 153.76, P < 0.001) in Zimbabwe. CONCLUSIONS: POC confers significant advantage on the proportion of caregivers receiving timely EID results, and improves time to results receipt and treatment initiation for infected infants. Where laboratory-based EID systems are unable to deliver results to caregivers rapidly, POC should be implemented as part of an integrated testing system.

Strengthening Existing Laboratory-Based Systems vs. Investing in Point-of-Care Assays for Early Infant Diagnosis of HIV: A Model-Based Cost-Effectiveness Analysis.

BACKGROUND: To improve early infant HIV diagnosis (EID) programs, options include replacing laboratory-based tests with point-of-care (POC) assays or investing in strengthened systems for sample transport and result return. SETTING: We used the CEPAC-Pediatric model to examine clinical benefits and costs of 3 EID strategies in Zimbabwe for infants 6 weeks of age. METHODS: We examined (1) laboratory-based EID (LAB), (2) strengthened laboratory-based EID (S-LAB), and (3) POC EID (POC). LAB/S-LAB and POC assays differed in sensitivity (LAB/S-LAB 100%, POC 96.9%) and specificity (LAB/S-LAB 99.6%, POC 99.9%). LAB/S-LAB/POC algorithms also differed in: probability of result return (79%/91%/98%), time until result return (61/53/1 days), probability of initiating antiretroviral therapy (ART) after positive result (52%/71%/86%), and total cost/test ($18.10/$30.47/$30.71). We projected life expectancy (LE) and average lifetime per-person cost for all HIV-exposed infants. We calculated incremental cost-effectiveness ratios (ICERs) from discounted (3%/year) LE and costs in $/year-of-life saved (YLS), defining cost effective as an ICER <$580/YLS (reflecting programs providing 2 vs. 1 ART regimens). In sensitivity analyses, we varied differences between S-LAB and POC in result return probability, result return time, ART initiation probability, and cost. RESULTS: For infants who acquired HIV, LAB/S-LAB/POC led to projected one-year survival of 67.3%/69.9%/75.6% and undiscounted LE of 21.74/22.71/24.49 years. For all HIV-exposed infants, undiscounted LE was 63.35/63.38/63.43 years, at discounted lifetime costs of $200/220/240 per infant. In cost-effectiveness analysis, S-LAB was an inefficient use of resources; the ICER of POC vs. LAB was $830/YLS. CONCLUSIONS: Current EID programs will attain greater benefit from investing in POC EID rather than strengthening laboratory-based systems.

Effectiveness of Maternal Transmission Risk Stratification in Identification of Infants for HIV Birth Testing: Lessons From Zimbabwe.

BACKGROUND: In 2017, Zimbabwe adopted a modified version of the World Health Organization 2016 recommendation on HIV birth testing by offering HIV testing at birth only to infants at "high risk" of HIV transmission. There is limited evidence on the effectiveness of this approach. Our study assessed the sensitivity and specificity of birth testing "high risk" infants only. METHODS: We conducted a cross-sectional study at 10 health facilities from November 2018 to July 2019. A nucleic acid test for HIV was performed on all HIV-exposed infants identified within 48 hours of life, irrespective of risk status. Univariate and bivariate analyses were used to estimate the performance of the risk screening tool. RESULTS: HIV nucleic acid test was successfully performed on 1970 infants (95%), of whom 266 (13.5%) were classified as high-risk infants. HIV prevalence for all infants tested was 1.5% (95% CI: 1% to 2%), whereas prevalence among high-risk infants and low-risk infants was 6.8% (95% CI: 3.7% to 9.8%) and 0.6% (95% CI: 0.3% to 1%) respectively. Sensitivity and specificity of the maternal risk screening tool was at 62.1% (95% CI: 44.4% to 79.7%) and 87.2% (95% CI: 85.7% to 88.7%), respectively; positive and negative predictive values were 6.8% (95% CI: 3.7% to 9.8%) and 99.4% (95% CI: 99.0% to 99.7%) respectively. CONCLUSIONS: Despite high negative predictive value, sensitivity was relatively low, with potential of missing 2 in every 5 HIV infected infants. Given the potential benefits of early ART initiation for all exposed infants, where feasible, universal testing for HIV-exposed infants at birth may be preferred to reduce missing infected infants.

"We Need it the Same Day": A Qualitative Study of Caregivers and Community Members' Perspectives Toward the Use of Point-of-Care Early Infant Diagnosis.

BACKGROUND: Only half of the infants tested for HIV ever receive results, leading to low uptake of treatment and increased mortality and morbidity rates. Point-of-care (POC) nucleic acid diagnostic machines allow for the possibility of same-day results. In Kenya and Zimbabwe, as part of an evaluation comparing standard of care with POC testing for early infant diagnosis, a qualitative substudy was undertaken to understand the acceptability of POC among caregivers of HIV-exposed infants and community members. SETTING: Kenya and Zimbabwe. METHODS: In Kenya, 74 interviews were conducted with caregivers, and 6 focus group discussions were conducted with male and female community members and elders. In Zimbabwe, we conducted 85 interviews and 8 focus group discussions. Data were collected in 2 rounds: 1 before the introduction of POC platforms and 1 after the platforms had been in use for at least 3 months. Interviews were conducted in local languages, and content analysis and constant comparison were used to identify key themes. RESULTS: Reduced time to receive test results lowered caregiver anxiety about the child's HIV status and allowed families to put children on treatment earlier. Printed POC results were seen by some as more trustworthy than conventional handwritten results, believing this reduced the chance of human error; a few distrusted HIV results were generated too quickly. Community awareness of POC was lower among caregivers of HIV-exposed infants. CONCLUSION: Caregivers are generally very accepting of receiving POC HIV test results; however, additional sensitization among influential community members about the benefits of POC testing is needed.

Estimating the Cost of Point-of-Care Early Infant Diagnosis in a Program Setting: A Case Study Using Abbott m-PIMA and Cepheid GeneXpert IV in Zimbabwe.

BACKGROUND: Point-of-care early infant diagnosis (POC EID) increases access to HIV test results and shortens time to result-return and antiretroviral therapy initiation, as compared to central laboratory-based EID. However, to scale-up POC EID, governments need more information about programmatic costs. METHODS: We evaluated POC EID costs from a health systems perspective. Our primary analysis assessed the Abbott m-PIMA and 2 versions of the Cepheid GeneXpert IV platforms-with a solar battery or gel battery-used in Zimbabwe, with instrument purchase. We also included the following 2 scenarios with zero upfront equipment purchase: (1) m-PIMA using a reagent rental model, with an all-inclusive price when the buyer commits to an average testing volume, and (2) GeneXpert IV, reflecting contexts where GeneXpert is already in place for tuberculosis diagnosis or HIV viral load monitoring. We collected data from project expenditures, observations of health workers, and from government salary scales. We calculated cost per EID test based on number of EID tests performed on each machine per day. RESULTS: The cost per successfully completed test was $44.55 for m-PIMA with platform purchase and $25.89 for m-PIMA reagent rental. Costs for GeneXpert IV with platform purchase were $25.70 using a solar battery, $25.29 using a gel battery, and $23.85 under a scenario assuming no equipment costs. In our primary analyses, materials costs comprised 73%-74% total costs, equipment 14%-20%, labor 5%-8%, training 1%, facility upgrades 1%, and monitoring 1%. CONCLUSIONS: As countries consider scaling up POC EID, these data are important for budgeting and planning.

Front-Line Human Resource Time-Use for Early Infant HIV Diagnosis: A Comparative Time-Motion Study at Centralized and Point-of-Care Health Facilities in Zimbabwe.

BACKGROUND: Point-of-care (POC) assays for early infant diagnosis of HIV (EID) increase access to testing, shorten time to results, and expedite initiation of antiretroviral therapy when compared with laboratory-based assays. However, there is a significant gap in our understanding of its human resource impact at the facility level. This study evaluates front-line health workers' (HWs') time associated with EID. SETTING: Using time-motion methodology, we collected time-use data on EID tasks performed by HWs at 3 EID facility types in Zimbabwe-5 POC hubs, 9 POC spokes, and 11 facilities that used centralized laboratories. METHODS: Data collectors observed 30 EID processes and 30 HWs' provided self-reported time. Comparisons of mean differences of HWs' time-use between centralized and POC EID were performed with a 2-sample t test with unequal variances. RESULTS: Observed average total labor time per EID test at POC facilities was 28 minutes, 22 seconds [95% confidence interval (CI): 22:51 to 35:48], which was equivalent to the average preresult time at facilities using centralized EID. HWs performed other tasks while the machine processed samples. Observed average preresult time (counseling to sample preparation) was 18 minutes, 6 Supported by seconds (95% CI: 13:00 to 23:42) for POC compared with 27 minutes, 48 seconds (95% CI: 23:48 to 32:50) for facilities using centralized laboratories. The mean difference of 9 minutes, 42 seconds (95% CI: 03:04 to 16:18) was statistically significant. The differences in self-reported average total labor time per EID test between HWs at facilities using centralized laboratories or POC were not statistically significant. CONCLUSION: Use of POC assays did not incur additional human resource time compared with sending dried blood spots to a centralized laboratory for EID.

Task shifting for point-of-care early infant diagnosis: a comparison of the quality of testing between nurses and laboratory personnel in Zimbabwe.

BACKGROUND: To decentralize point-of-care early infant diagnosis (POC EID), task shifting to cadres such as nurses is important. However, this should not compromise quality of testing through generating high rates of internal quality control (IQC) failures and long result turnaround times. We used data from a POC EID project in Zimbabwe to compare IQC rates and result return to caregivers for samples run on a POC EID technology (Alere q HIV 1/2 Detect) between nurses and laboratory-trained personnel to assess effects of task shifting on quality of testing. METHODS: This cross-sectional retrospective study used data from all 46 sites (10 hub and 36 spoke sites in Zimbabwe that piloted POC EID for routine clinical use from December 2016 to June 2017). IQC failure rates were downloaded from each POC EID platform and exported to excel to analyze IQC failure rates by type of operator. Turnaround time (TAT) from sample collection to issuing of results to caregiver was extracted from the EID test request form and uploaded into a project specific Excel-based database for analysis. RESULTS: A total of 1847 tests were conducted by 45 testers (12 laboratory-trained and 33 non-laboratory-trained personnel), including 165 errors. There were no significant differences in IQC failure rates between non-laboratory testers (137 [9.2%] of 14830 tests) and specialized laboratory-trained (28 [7.7%] of 364 tests; p = 0.354). Over time, IQC failure rates for both non-laboratory (χ2 = 18.5, p < 0.000) and specialized laboratory-trained testers (χ2 = 8.7, p < 0.003) decreased significantly. There were similar proportions of clients who were issued with results between samples processed by non-laboratory testers (1283 [98.9%] of 1297 tests) and samples processed by specialized laboratory-trained testers (315 [98.7%] of 319 tests; p = 0.790). The overall median turnaround time from sample collection to receipt of results by caregiver for samples run by laboratory-specialized testers was not statistically different from samples run by non-laboratory-specialized testers (1 day [IQR 0-3] versus 0 days [IQR 0-2]; p = 0.583). CONCLUSIONS: Similar IQC failure rates and TATs between non-laboratory and specialized laboratory-trained operators suggest that non-specialized laboratory-trained personnel can perform POC EID equally well as specialized laboratory personnel.